Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients
NCT ID: NCT05566613
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
550 participants
OBSERVATIONAL
2022-05-09
2024-12-31
Brief Summary
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Detailed Description
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1. To explore if acute radiation response can be predicted in patients, by analyzing a single nucleotide polymorphism (SNP rs1801516) sampled prior to radiotherapy.
2. If acute radiation response can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled prior to radiotherapy.
3. If late side effects from radiotherapy can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled before and after radiotherapy.
4. If there is a correlation between genetic and inflammatory markers in blood and patient reported outcome measures (PROM) and quality of life (QoL).
5. To train an algorithm to correlate the appearance of skin before radiotherapy and the extent of skin reaction to radiotherapy
Outline This study is a non-randomized clinical cohort study. Adults with breast cancer will be invited to participate in the study. Blood will be collected before start of treatment and after radiotherapy is completed. Quality of life (QoL) and symptoms will be assessed before and weekly during treatment, at the end of treatment and after one year. A total of 550 patients is expected to be recruited.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Blood sample
Blood sample before and after radiotherapy and photography before radiotherapy
Eligibility Criteria
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Inclusion Criteria
* \> 18 years
* Being able to read and understand patient information in Swedish
* Signed informed consent
Exclusion Criteria
* Fever \>37,9 degrees Celsius
* Unable to follow study protocol
18 Years
ALL
No
Sponsors
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Stockholm University
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Mattias Hedman
Head of Radiotherapy
Principal Investigators
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Mattias Hedman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21/079
Identifier Type: -
Identifier Source: org_study_id
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